BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R) LONG

    MDR report key: 1823032 · Received September 1, 2010

    Report

    Report Number
    2134265-2010-03823
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER - (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS A DUPLICATE OF : 2134265-2010-05215. IT WAS FURTHER REPORTED THAT THE 50-70% IN-STENT RESTENOSIS WAS IDENTIFIED IN THE DISTAL LEFT CIRCUMFLEX (CX) INSTEAD OF THE LPL AS INITIALLY REPORTED.

    Description of Event or Problem · 1

    (B)(6). SAME CASE AS: 2134265-2010-03822. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS MYOCARDIAL ISCHEMIA. THE PATIENT PRESENTED DUE TO CURRENT UNSTABLE ANGINA. LESION 1 WAS LOCATED IN THE LEFT POSTEROLATERAL (LPL). THE LESION WAS 80% STENOSED, 2.5MM IN DIAMETER AND 5MM LONG. THE TARGET LESION WAS TREATED WITH DIRECT STENTING WITH THE PLACEMENT OF A 2.75X12MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. LESION 2 WAS A BIFURCATED LESION LOCATED IN THE 1ST DIAGONAL. THE LESION WAS 95% STENOSED, 2.5MM IN DIAMETER AND 30MM LONG. THE TARGET LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.75X38MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL. IN (B)(6) 2010, THE PATIENT EXPERIENCED MYOCARDIAL ISCHEMIA AND UNDERWENT CARDIAC CATHETERIZATION. A 95% IN-STENT RESTENOSIS WAS IDENTIFIED IN THE 1ST DIAGONAL. THE LESION WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.75X28MM NON-BSC STENT. RESIDUAL STENOSIS WAS 0%. A 50-70% IN-STENT RESTENOSIS WAS IDENTIFIED IN THE LPL. THE LESION WAS TREATED WITH DIRECT STENTING AND PLACEMENT OF A 2.75X18MM NON-BSC STENT. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) LONG CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893638270 0012783212

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention